Policy & Compliance

  • May 29, 2024

    Israeli Atty Cops To Aiding Convicted Ponzi Schemer In NJ

    An Israeli attorney has admitted to conspiring to commit securities fraud, launder money and obstruct justice to aid alleged serial fraudster Eliyahu "Eli" Weinstein, who is facing new fraud charges just two years after then-President Donald Trump commuted Weinstein's 24-year prison sentence for previous fraud convictions amid a flood of last-minute pardons in January 2021.

  • May 29, 2024

    Whistleblower Counsel Can't Get 'Exorbitant' $11.5M Fee

    A Boston federal judge slashed an "exorbitant" $11.5 million fee request made by counsel for a False Claims Act whistleblower in a case involving lab testing company Fresenius Medical Care, hammering the attorneys for inflated hourly rates, inflated time entries and a host of questionable billing practices.

  • May 28, 2024

    Staffing Rule Suit, Mayo COVID Claims And An Oathless Expert

    Nursing home trade groups sue over "nightmare" staffing rule, former Mayo Clinic workers get another shot at claims they were illegally fired over COVID-19 policy breaches, and an unsworn expert letter tanks a medical malpractice suit in Iowa. Law360 Healthcare Authority looks at those and other notable developments in healthcare litigation over the past week.

  • May 28, 2024

    Alaska Opioid Suit Moves Forward In Early Loss For PBMs

    An Alaska federal judge is allowing public nuisance claims to move forward against Express Scripts as pharmacy benefit managers are increasingly targeted in opioid litigation.

  • May 28, 2024

    5th Circ. Flips Cancer-Drug Maker's Defeat In Hair Loss MDL

    The Fifth Circuit has vacated a summary judgment ruling in favor of four women who say two drugmakers failed to warn consumers that their chemotherapy drug could cause hair loss, saying it was impossible for the companies to simultaneously comply with federal and state failure-to-warn laws.

  • May 28, 2024

    Healthcare Tech Co. To Pay $1.5M To End Class Wage Claims

    A healthcare software consulting company agreed to a $1.5 million deal resolving claims it violated Washington state wage law by requiring its software training staff to work up to 80 hours and seven days a week, according to a motion to approve the deal filed in federal court.

  • May 28, 2024

    The Most Likely Healthcare Targets In A Post-Chevron World

    Attorneys in the healthcare arena have a keen interest in a U.S. Supreme Court challenge to the Chevron deference doctrine, particularly in light of the sheer volume of guidance issued by the U.S. Department of Health and Human Services and its subsidiary agencies. With the high court now poised to decide Chevron’s fate, Law360 looks at health law that could be targeted in a post-Chevron world.

  • May 28, 2024

    Nursing Co. Strikes Deal To End EEOC Misgendering Probe

    A Washington nursing facility has reached a deal with the U.S. Equal Employment Opportunity Commission to settle a charge from a worker who said the business sat idle while co-workers repeatedly and intentionally referred to them by the wrong pronouns.

  • May 28, 2024

    Edwards Urges Full Fed. Circ. To Limit FDA Safe Harbor

    Edwards Lifesciences has petitioned the full Federal Circuit to narrow its interpretation of a U.S. Food and Drug Administration safe harbor that essentially allows patent infringement during drug development, arguing that if Congress wanted the statute to be interpreted broadly, "it would have said exactly that."

  • May 28, 2024

    'Creative' Suits Aim To End Secret Arbitration At Ariz. Facilities

    Arizona's top law enforcement official is pursuing an unusual series of legal challenges that aim to strike down confidential arbitration agreements at long-term care facilities and shine a light on allegations of elder abuse or neglect.

  • May 23, 2024

    RFK Jr.'s Anti-Vax Suit Against Wash. AG Tossed

    A Washington federal judge has dismissed a lawsuit brought by Robert F. Kennedy Jr. on behalf of NBA legend John Stockton trying to shield doctors who make anti-vaccine statements, ruling claims that a medical board probe has chilled speech are speculative.

  • May 23, 2024

    NJ Justices Toss Direct Appeals Over Hospital Contract Bid

    The New Jersey Supreme Court ruled Thursday that an independent state-owned teaching hospital's conduct cannot be challenged directly in the state's intermediate appellate court because it isn't considered an administrative agency, affirming the dismissal of two protests over the hospital's selection of a pharmacy vendor.

  • May 23, 2024

    UBH Urges 9th Circ. To Take Up Petition In Health Claim Fight

    United Behavioral Health implored the Ninth Circuit to grant the insurance company's petition for appellate court intervention in a consolidated action alleging mismanagement of mental health and substance use disorder treatment claims, arguing a California federal court clearly erred by allowing further pleadings on a denial of benefits claim.

  • May 23, 2024

    Ambulance Co. Owner Accused Of $1M Pandemic Loan Fraud

    The owner of a California ambulance company who was charged last year with tax evasion and filing false returns has been further accused of fraudulently securing $1 million from federal pandemic relief loan programs, according to the U.S. Department of Justice.

  • May 23, 2024

    Cancer Society Strategist Starts 'New Adventure' With Venable

    Venable LLP has hired the former strategic director for the American Cancer Society's Cancer Action Network as a senior policy adviser for its legislative and government affairs practice group and its health policy team.

  • May 22, 2024

    Wash. Health System Wants $230M Worker Class Win Axed

    A Washington hospital system is seeking to derail a nearly $230 million judgement in favor of workers in a class wage case, contending the plaintiffs' key expert who testified at a state court trial recommended that jurors calculate damages based on a flawed equation that didn't account for differences in pay classifications.

  • May 22, 2024

    NC Panel Revives Retention Claim In Faulty Back Surgery Suit

    A North Carolina appeals court has revived a family's negligent retention claim against a clinic over a doctor who was ousted from the profession for unnecessary and faulty surgeries, finding the claim does not fall under the state's four-year statute of repose for medical malpractice claims.

  • May 22, 2024

    Anti-Abortion Activist Gets Two Years For DC Clinic Blockade

    An anti-abortion activist convicted of invading and blockading a Washington, D.C., reproductive health clinic was sentenced to two years of incarceration Wednesday, becoming the ninth defendant to get prison time in the D.C. federal court case.

  • May 21, 2024

    FTC Noncompete Ban Raises Stakes For Nonprofit Hospitals

    The Federal Trade Commission seems eager to apply its employee noncompete ban to healthcare, with a key target in mind: nonprofit healthcare providers that, in the agency's view, act more like for-profit businesses.

  • May 21, 2024

    Judge Shopping Row, Henrietta Lacks And SC Abortion Clock

    BigLaw lawyers get deeper into sanction spat, a case over profits from harvested cancer cells, and a Texas Supreme Court decision in a Fen-Phen malpractice suit. Law360 Healthcare Authority looks at those and other developments from the week in healthcare litigation.

  • May 21, 2024

    DC Circ. Says Drugmakers Can Limit Pharmacy Discounts

    The D.C. Circuit held Tuesday that a federal drug discount program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies, rejecting the U.S. Department of Health and Human Services' expansive interpretation of the 340B drug pricing program.

  • May 21, 2024

    Mich. Judge Doubts Abortion Laws Pass Constitutional Muster

    A Michigan state judge on Tuesday was skeptical state regulators could impose a waiting period and other requirements on people seeking abortions without violating a state constitutional amendment enshrining the right to abortion.

  • May 21, 2024

    NY High Court Upholds State Abortion Coverage Mandate

    New York's highest court on Tuesday upheld a state law requiring employee health plans to cover medically necessary abortions, finding a 2021 U.S. Supreme Court decision didn't change the state court's determination that an exemption process in the law was constitutional.

  • May 21, 2024

    Counties Not 'Persons' In Texas Opioid MDL Appeal

    A Texas appeals panel found Tuesday that counties are not considered "persons" under the state's common law and therefore are not subject to the Texas Medical Liability Act's requirement that they serve expert reports to pharmacy defendants in the state's opioid multidistrict litigation.

  • May 21, 2024

    Custom Drug Makers Stay On DOJ Radar In Fla. Fraud Case

    Federal law enforcement's stake in a recent whistleblower lawsuit focused on expensive skin creams shows the agency's focus on pharmacies providing custom medications — long recognized as a lucrative avenue for Medicare fraudsters — hasn't waned.

Expert Analysis

  • 3rd Circ.'s Geico Ruling May Encourage Healthcare Arbitration

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    The Third Circuit's recent decision in Geico v. Mount Prospect, finding that claims under New Jersey's Insurance Fraud Prevention Act can be arbitrated, strengthens arbitration as a viable alternative to litigation, even though it is not necessarily always a more favorable forum, say Khaled Klele and Jessica Osterlof at McCarter & English.

  • Proposed Cannabis Reschedule Sidesteps State Law Effects

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    The U.S. Department of Justice's recent proposal to move cannabis to Schedule III of the Controlled Substances Act provides certain benefits, but its failure to address how the rescheduling would interact with existing state cannabis laws disappointed industry participants hoping for clarity on this crucial question, says Ian Stewart at Wilson Elser.

  • A Changing Regulatory Landscape For Weight Loss Drugs

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    As drugs originally approved to treat diabetes become increasingly popular for weight loss purposes, federal and state regulators and payors are increasing their focus on how these drugs are prescribed, and industry participants should pay close attention to rapidly evolving compliance requirements, say attorneys at Goodwin.

  • Opioid Suits Offer Case Study In Abatement Expert Testimony

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    Settlements in the opioid multidistrict litigation provide useful insight into leveraging expert discovery on abatement in public nuisance cases, and would not have been successful without testimony on the costs necessary to lessen the harms of the opioid crisis, says David Burnett at DiCello Levitt.

  • How HHS Discrimination Rule Affects Gender-Affirming Care

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    The U.S. Department of Health and Human Services' new final rule, which reinterprets the Affordable Care Act's anti-discrimination provision, greatly clarifies protections for gender-affirming care and will require compliance considerations from sponsors and administrators of most group health plans, say attorneys at McDermott.

  • FTC Noncompete Rule's Impact On Healthcare Nonprofits

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    Healthcare entities that are nonprofit or tax-exempt and thus outside of the pending Federal Trade Commission noncompete rule's reach should evaluate a number of potential risk factors and impacts, starting by assessing their own status, say Ben Shook and Tania Archer at Moore & Van Allen.

  • Key Takeaways From FDA Final Rule On Lab-Developed Tests

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    Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.

  • Assessing HHS' Stance On Rare Disease Patient Assistance

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    The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.

  • Are Concessions In FDA's Lab-Developed Tests Rule Enough?

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    Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.

  • 8 Questions To Ask Before Final CISA Breach Reporting Rule

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    The Cybersecurity and Infrastructure Security Agency’s recently proposed cyber incident reporting requirements for critical infrastructure entities represent the overall approach CISA will take in its final rule, so companies should be asking key compliance questions now and preparing for a more complicated reporting regime, say Arianna Evers and Shannon Mercer at WilmerHale.

  • Mid-2024 FCA Enforcement And Litigation Trends To Watch

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    Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.

  • Online Portal Helps Fortify Feds' Unfair Health Practices Fight

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    The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.

  • McKesson May Change How AKS-Based FCA Claims Are Pled

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    The Second Circuit’s analysis in U.S. v. McKesson, an Anti-Kickback Statute-based False Claims Act case, provides guidance for both relators and defendants parsing scienter-related allegations, say Li Yu at Dicello Levitt, Ellen London at London & Stout, and Erica Hitchings at Whistleblower Law.